Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People
NCT ID: NCT03520361
Last Updated: 2018-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
198 participants
INTERVENTIONAL
2017-11-02
2019-06-30
Brief Summary
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Detailed Description
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The aim of study is to compare oral sulfate solution (OSS) with 2L polyethylene glycol (PEG) with ascorbic acid (Asc) for bowel preparation in elderly people.
99 participants will be enrolled in each group (198 in total). The primary outcome is the efficacy of bowel preparation. Secondary outcomes are tolerability, satisfaction, and safety.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Oral sulfate solution (OSS) taking group
On the evening before colonoscopy, drink 177ml of OSS (Suclear®) (473ml including water in container), additionally allow another 946 ml of water. On the day of colonoscopy, drink 177ml of OSS (473ml including water in container), additionally allow another 946 ml of water.
Oral sulfate solution (OSS)
Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g
2L PEG/Asc taking group
On the evening before colonoscopy, drink 1L of 2L PEG/Asc (Haprep®) solution, additionally allow another 500 ml of water. On the day of colonoscopy, drink 1L of 2L PEG/Asc solution, additionally allow another 500 ml of water.
2L PEG/Asc
Compositions/1L : Sodium chloride 2.89g, Potassium chloride 1.015g, Anhydrous sodium sulfate 7.5g, Polyethylene glycol 3350 100g, Ascorbic acid 4.7g, Sodium ascorbate 5.9g
Interventions
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Oral sulfate solution (OSS)
Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g
2L PEG/Asc
Compositions/1L : Sodium chloride 2.89g, Potassium chloride 1.015g, Anhydrous sodium sulfate 7.5g, Polyethylene glycol 3350 100g, Ascorbic acid 4.7g, Sodium ascorbate 5.9g
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Examinee agree with informed consent
Exclusion Criteria
* Bowel obstruction
* Severe constipation (\<3 bowel movements per week with or without regular or intermittent laxatives)
* History of bowel surgery
* Liver cirrhosis or ascites
* Heart failure, cardiac disease (ischemic heart disease or coronary artery disease within the last 6 months)
* Inflammatory bowel disease
* Pregnancy, lactating woman
* Renal impairment or history of impaired renal function
* History of hypersensitivity reaction to bowel preparation
65 Years
80 Years
ALL
No
Sponsors
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KangWon National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Sung Chul Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
KangWon National University Hospital
Locations
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Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea
Countries
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Other Identifiers
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2017-03-011
Identifier Type: -
Identifier Source: org_study_id
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